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A phase II/III, observer-blind, randomised, active controlled study to compare the safety and immunogenicity of a meningococcal A conjugate vaccine (PsA-TT) with meningococcal ACWY polysaccharide vaccine administered in healthy children 2 to 10 years of age
ISRCTN ISRCTN46335400
DOI 10.1186/ISRCTN46335400
ClinicalTrials.gov identifier
EudraCT number
Public title A phase II/III, observer-blind, randomised, active controlled study to compare the safety and immunogenicity of a meningococcal A conjugate vaccine (PsA-TT) with meningococcal ACWY polysaccharide vaccine administered in healthy children 2 to 10 years of age
Scientific title
Acronym N/A
Serial number at source RPC219; PsA-TT-003a
Study hypothesis Bacterial meningitis is a life-threatening medical emergency. Morbidity includes hearing loss, chronic seizures, and learning disability. The principal pathogens of bacterial meningitis are Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae type B. Neisseria meningitidis is particularly feared because it has the capability of causing large outbreaks of disease. Endemic meningococcal disease occurs worldwide and is mostly caused by meningococci of serogroups A, B, C, W135 and Y.

Hypothesis:
To compare the immunogenicity of a single dose of the PsA-TT vaccine with that of the Meningococcal A component of the PsACWY vaccine at 28 days after vaccination.
Lay summary
Ethics approval Ethics approval received from the King Edward Memorial Hospital Ethics Committee, Pune, India, on the 1st August 2007.
Study design Phase II/III, observer-blind, randomised, active controlled study
Countries of recruitment India
Disease/condition/study domain Bacterial meningitis
Participants - inclusion criteria A subject will be eligible for inclusion if ALL of the following apply at the time of enrolment:
1. Age 2 to 10 years of age (both included)
2. Written informed consent obtained from parents or legal guardian of the child
3. Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator
4. Parents or legal guardian capable and willing to bring their child or to receive home visits (for their child) for all follow-up visits
5. Residence in the study area
6. Fully vaccinated according to the local Expanded Program on Immunisation (EPI) schedule
Participants - exclusion criteria Subjects with any of the following criteria at study entry will not be eligible for participation:
1. Previous vaccination against Neisseria meningitidis
2. Known exposure to Neisseria meningitidis during the three previous months
3. History of allergic disease or known hypersensitivity to any component of the two study vaccines and/or following administration of vaccines included in the local program of immunisation
4. Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination during the first 28 days after the study vaccination
5. Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines
6. Administration of immunoglobulins and/or any blood products within 30 days prior to the administration of study vaccines or planned administration during the study period
7. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within 90 days prior to the administration of study vaccines (including systemic or inhaled corticosteroids, this means prednisone, or equivalent, greater than 0.5 mg/kg/day; topical steroids are allowed)
8. A family history of congenital or hereditary immunodeficiency
9. History of meningitis or seizures or any neurological disorder
10. Major congenital defects or serious chronic illness, including malnutrition (as per investigator's judgment)
11. Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever) is a temporary exclusion
12. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination or laboratory tests, which in the opinion of the investigator, might interfere with the study objectives
13. Any condition or criteria that in the opinion of the investigator might compromise the well being of the subject or the compliance with study procedures or interfere with the outcome of the study
14. Non residence in the study area or intent to move out within one year
Anticipated start date 20/08/2007
Anticipated end date 20/11/2007
Status of trial Completed
Patient information material
Target number of participants 340
Interventions 1. One 0.5 ml dose out of a decadose vial of PsA-TT vaccine will be injected intramuscularly (IM) in the right deltoid
2. One 0.5 ml dose of PsACWY vaccine will be injected IM in the right deltoid

Joint sponsor:
Program for Appropriate Technology in Health (PATH) (USA)
1455 NW Leary Way
Seattle
WA 98107
U.S.A.
Tel: +1 206 285 3500
Fax: +1 206 285 6619

Principal Investigator:
Dr Anand Pandit
Department of Pediatrics
King Edward Memorial Hospital Research Centre
Sardar Moodliar Road
Rasta Peth
Pune 411011
India
Tel: +91 (0)20 26125600
Fax: +91 (0)20 26125603
Primary outcome measure(s) The percentage of subjects who show a seroconversion for anti-Meningococcal Polysaccharide A (MenPsA) antibodies, i.e., a four-fold increase in post-immunisation serum titre with respect to pre-immunisation serum titre, at 28 days after a single vaccine dose, as measured by a rabbit complement Serum Bactericidal Assay (rSBA).
Secondary outcome measure(s) Safety:
1. The percentage of subjects with local and systemic post-immunisation reactions during the first four days, adverse events and Serious Adverse Events (SAEs), as measured at 4 and 28 days after vaccination (reactogenicity and short-term safety)
2. The percentage of subjects with SAEs during the entire study duration, as measured at 182 days (6 months) and 364 days (1 year) (long-term safety)

Immunogenicity:
1. The percentage of subjects with anti-MenPsA titre greater than or equal to 1:8 (defined as seroprotection to MenA) at 28 days after a single vaccine dose, as measured by rSBA assay. The percentage of subjects with anti-MenPsA titer greater than or equal to 1:128 (defined as long-term seroprotection to MenA) will be also considered
2. Geometric Mean Titres (GMTs) for anti-MenPsA antibodies at 28 days after a single vaccine dose, as measured by rSBA assay
3. Evaluation of reverse cumulative distribution curves for MenPsA antibody titres at 28 days after a single vaccine dose, as measured by rSBA assay
4. The percentage of subjects who show a seroconversion for anti-MenPsA total Immunoglobulin G (IgG), i.e. a two-fold increase in post-immunisation serum concentration with respect to pre-immunisation serum concentration, at 28 days after a single vaccine dose, as measured by Enzyme-Linked Immunosorbent Assay (ELISA). The percentage of subjects with a four-fold increase in post-immunisation serum concentration with respect to pre-immunisation serum concentration will be also considered
Sources of funding The Bill and Melinda Gates Foundation (USA)
Trial website http://www.meningvax.org
Publications
Contact name Dr  Marie-Pierre  Preziosi
  Address Initiative for Vaccine Research
World Health Organization (WHO)
Department of Immunisation, Vaccines and Biologicals (IVB)
20 Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH-1211
  Country Switzerland
  Tel +41 (0)22 791 3744
  Fax +41 (0)22 791 4860
  Email preziosim@who.int
Sponsor Serum Institute of India Limited (SIIL) (India)
  Address 212/2, Hadapsar
  City/town Pune
  Zip/Postcode 411 028
  Country India
  Sponsor website: http://www.seruminstitute.com/
Date applied 14/08/2007
Last edited 11/09/2007
Date ISRCTN assigned 14/08/2007
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